The Product Conformity Verification based on Annex XI of the MDR may be carried out for the medical devices with EU type-examination Certificate for conformance to the type specified. The manufacturer may apply either for the EU Quality Assurance Certificate or for the EU Product Verification Certificate.
EU Quality Assurance Certificate: This certificate is issued for the medical devices that apply for the Product Conformity Verification and that comply to the conformity assessment of production quality assurance specified in the Annex XI part A. This certificate includes the identification of devices or group of devices, the risk classification and for Class IIb, intended purpose also.
EU Product Verification Certificate: This certificate is issued for the medical devices that apply for the Product Conformity Verification and that comply with the conformity assessment of product verification specified in Annex XI part B. Class IIa devices may apply for this certificate without the EU Type -Examination Certificate as an exemption. This certificate includes product identification (name, model, type of device or devices), intended purpose, risk classification, and Basic UDI- DI.
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During the surveillance of medical devices with the EU quality assurance certificate, what is the extra step required for the class III device? What are the special exemptions available for a class IIa device that is applying for product verification?
In the case of class III devices, the surveillance assessment shall also include a test of the approved parts and/or materials that are essential for the integrity of the device, including, where appropriate, a check that the quantities of produced or purchased parts and/or materials correspond to the quantities of finished devices.
Class IIa devices are exempted from EU type-examination certificate (clauses 1 and 2 of Annex XI) in accordance with Annex X when opting for conformity assessment based on part A and Part B of Annex XI.
There are two questions, one is linked to Part A and the other linked to Part B of Annex XI of EU MDR. Part A mentions Production Quality Assurance and Part B mentions Product Verification of Annex XI.
For the first question,
As per Section 7, Part A of EU MDR Annex XI, for the Class III devices,
during the surveillance, the quantities of produced and/or purchased raw materials or crucial components are verified with the corresponding quantities of finished devices.
For the second question,
As per Section 18, Part B of EU MDR Annex XI,
the manufacturer shall be deemed to ensure and declare that the class IIa devices are manufactured in conformity with the technical documentation. And the notified body issue a certificate in accordance with the Part B of the Annex XI, after verification of the following,
the technical documentation as per Annexes II and III of EU MDR &
the requirements of EU MDR applying to the particular Class IIa devices
Production Quality Assurance Certificate:- For class III devices- during the surveillance, the quantities of produced or purchased raw materials or crucial parts/components are checked against the quantities of finished devices.
For Class IIa devices:- The manufacturer shall ensure and declare that the class IIa devices are manufactured in conformity with the technical documentation referred to in Annexes II and III of EU MDR 2017/745 and meet the requirements of this Regulation which apply to them. Notified body verify the conformity of class IIa devices by verifying the technical documentation as referred to in Annexes II and III